Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth.

Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.

Device Description

Visalys® Bulk Fill is a light-cured, nano-hybrid filling composite that can be modeled and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in screw syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 82% inorganic fillers by weight. The radiopacity is 2.5 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Fill is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V.

Visalys® Bulk Flow is a light-cured, flowable nano-hybrid filling composite and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 72% inorganic fillers by weight. The radiopacity is 2.0 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Flow is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Capping is not necessary.

AI/ML Overview

The provided text focuses on the substantial equivalence of dental restorative materials (Visalys® Bulk Fill and Visalys® Bulk Flow) to a predicate device. It does not describe a device that uses AI or machine learning, nor does it detail acceptance criteria related to typical AI/ML performance metrics such as sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document describes traditional performance testing for dental materials, primarily focusing on physical and chemical properties and biocompatibility.

Here's an overview of the information present in the document that aligns with the context of a medical device submission, but not specifically for an AI/ML device:

1. Table of acceptance criteria and reported device performance:

The document lists performance tests conducted in accordance with various ISO standards for "Polymer-based restorative materials" (ISO 4049). It states that a "comparison of the parameters in respect to mechanical properties was performed. The results demonstrate the substantial equivalence to the predicate device." However, specific numerical acceptance criteria (e.g., "flexural strength > X MPa") and the reported numerical performance values for the subject devices are not explicitly stated in the provided text. It only mentions that the results demonstrate substantial equivalence.

Acceptance Criteria Category	Standard Used	Reported Device Performance
Sensitivity to light	ISO 4049 / 7.9	Results demonstrate substantial equivalence to the predicate device.
Depth of cure	ISO 4049 / 7.10	Results demonstrate substantial equivalence to the predicate device.
Flexural strength	ISO 4049 / 7.11	Results demonstrate substantial equivalence to the predicate device.
Elastic modulus	ISO 4049 / 7.11	Results demonstrate substantial equivalence to the predicate device.
Water sorption	ISO 4049 / 7.12	Results demonstrate substantial equivalence to the predicate device.
Solubility	ISO 4049 / 7.12	Results demonstrate substantial equivalence to the predicate device.
Shade of restorative materials	ISO 4049 / 7.13 & ISO 7491 / ANSI ADA Spec. 80	Results demonstrate substantial equivalence to the predicate device.
Color stability after irradiation and water sorption	ISO 4049 / 7.13 & ISO 7491 / ANSI ADA Spec. 80	Results demonstrate substantial equivalence to the predicate device.
Radio-opacity	ISO 4049 / 7.14 & ISO 13116	Results demonstrate substantial equivalence to the predicate device.
Volume shrinkage	ISO 17304	Results demonstrate substantial equivalence to the predicate device.
Shear bond strength to dentin	ISO 29022	Results demonstrate substantial equivalence to the predicate device.
Shear bond strength to restorative materials	ISO 29022	Results demonstrate substantial equivalence to the predicate device.
Duration of light curing	Internal test method	Results demonstrate substantial equivalence to the predicate device.
Extrusion force (Bulk Flow only)	Internal test method	Results demonstrate substantial equivalence to the predicate device.
Consistency (Bulk Fill only)	Internal test method	Results demonstrate substantial equivalence to the predicate device.
High shear viscosity (Bulk Flow only)	Internal test method	Results demonstrate substantial equivalence to the predicate device.
Low shear viscosity (Bulk Flow only)	Internal test methods	Results demonstrate substantial equivalence to the predicate device.
Universal color	In-vitro test	Results demonstrate substantial equivalence to the predicate device.
Biocompatibility (Cytotoxicity, Sensitization, Genotoxicity, Toxicological risk assessment, Chemical characterization)	ISO 10993-5, ISO 10993-10, ISO 10993-3, ISO 10993-17, ISO 10993-18, ISO 7405	Comparable to other materials on the market, no toxicological risks.

2. Sample size used for the test set and the data provenance: Not applicable. The tests are bench tests of material properties, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized physical/chemical testing, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the performance testing is based on established physical and chemical measurements defined by international ISO standards for dental materials.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary

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March 14, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

Kettenbach GmbH & Co. KG Marleen Steger Regulatory Affairs Manager Im Heerfeld 7 Eschenburg, 35713 Germany

Re: K250267

Trade/Device Name: Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: March 13, 2025 Received: March 13, 2025

Dear Marleen Steger:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K250267

Device Name

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo features six blue circles arranged in a triangular pattern above the text "KETTENBACH DENTAL" in a bold, blue font. Below the company name is the tagline "Simply intelligent" in a smaller, lighter blue font.

K250267 - 510(k) Summary

l. Submitter:

Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany

Phone: +49 2774 705 0 Fax: +49 2774 705 66

Contact person:

Steger, Marleen Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail: marleen.steger@kettenbach.com

Date of preparation:

March 14th, 2025

II.Device
Name of Device:	Visalys® Bulk Fill
Common or Usual Name:	Visalys® Bulk Fill
Classification Name:	Material, Tooth Shade, Resin (21 CFR 872.3690)
Regulatory Class:	II
Product Code:	EBF
Name of Device:	Visalys® Bulk Flow
Common or Usual Name:	Visalys® Bulk Flow
Classification Name:	Material, Tooth Shade, Resin (21 CFR 872.3690)
Regulatory Class:	II
Product Code:	EBF

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Image /page/5/Picture/0 description: The image features the logo for KETTENBACH DENTAL. The logo consists of a geometric design of six circles arranged in a triangular pattern above the company name. The text "KETTENBACH" is in a bold, sans-serif font, with "DENTAL" in a lighter, smaller font next to it. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.

= Predicate devices:

Venus Bulk Flow ONE (Kulzer, LLC), K220605 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. Device Description:

*Aluminium has the same radiopacity as dentin. 1 mm enamel corresponds to 2 mm aluminium.

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Image /page/6/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of a blue graphic of seven circles arranged in a triangular shape above the company name. Below the company name is the tagline "Simply intelligent" in a smaller font size.

> Indications for Use:

Visalys® Bulk Fill

Loss of tooth substance due to caries, fractures, dental wear or developmental disorders.

Techniques:

Class I and II restorations .
Non-tunneled class III restorations ●
Class V restorations ●
Fillings in deciduous teeth
Core build-ups
Cavity floor elevation ●
Repair of direct and indirect restorations after appropriate pretreatment ●
Splinting / locking of teeth ●

Visalys® Bulk Flow

Loss of tooth substance due to caries, fractures, dental wear or developmental disorders.

Techniques:

. Class I and II restorations
Non-tunneled class III restorations ●
Class V restorations ●
Fillings in deciduous teeth ●
Core build-ups ●
Cavity lining ●
Cavity floor elevation ●
Blocking out undercuts
Repair of direct and indirect restorations after appropriate pretreatment ●
Extended fissure sealing ●
Splinting / locking of teeth ●

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imply intelligent1=e
----------------------------------

able 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

	Predicate Devices	Substantial Equivalent Device		Conclusion
	Venus Bulk Flow ONE	Visalys® Bulk Fill	Visalys® Bulk Flow
Product
Manufacturer	Kulzer, LLC	Kettenbach GmbH & Co. KG
ProductDescription	Venus Bulk Flow ONE is aflowable, light-curing, radio-opaque nano-hybridcomposite.	Visalys® Bulk Fill is alight-cured, nano-hybridfilling composite that canbe modeled and isavailable in a universalshade.	Visalys® Bulk Flow is alight-cured, flowablenano-hybrid fillingcomposite and isavailable in a universalshade.	Visalys® Bulk Fill andVisalys® Bulk Flow aresimilar to Venus Bulk FlowOne. All are light-curednano-hybrid composites.
Intended purpose	Flowable light curing nanohybrid composite, radio-opaque	Universal nano-hybridrestorative composite,modelable	Universal nano-hybridrestorative composite,flowable	Visalys® Bulk Fill andVisalys® Bulk Flow aresimilar to Venus Bulk FlowOne. These are light-cured,nano-hybrid composites.Visalys® Bulk Fill ismodelable, Visalys® BulkFlow and Venus Bulk FlowONE are flowable. Thedifferences in viscosityhave no effect on theintended purpose. Visalys®Bulk Fill and Visalys® BulkFlow are radio-opaque likeVenus Bulk Flow ONE,which is not described inthe intended purpose.
Indications /Techniques	- Class -I, -II, -III and -Vdirect restorations- First-layer lining for class Iand II cavities- Repair of direct andindirect restorations incombination with a suitableadhesive- Splinting loosened teethresulting from trauma orperiodontal associatedevents	- Class I and IIrestorations- Non-tunneled class IIIrestorations- Class V restorations- Fillings in deciduousteeth- Core build-ups- Cavity floor elevation- Repair of direct andindirect restorations afterappropriate pretreatment	- Class I and IIrestorations- Non-tunneled class IIIrestorations- Class V restorations- Fillings in deciduousteeth- Core build-ups- Cavity lining- Cavity floor elevation- Blocking out undercuts	All Venus Bulk Flow ONEindications are covered byVisalys® Bulk Fill andVisalys® Bulk Flow.Visalys® Bulk Fill andVisalys® Bulk Flow canalso be used for fillings indeciduous teeth, corebuild-ups, cavity floorelevation and blocking outundercuts (just Visalys®Bulk Flow).
510k Summary		Rev.2		Page 4 von 8

510k Summary Issued: 2025-03-14

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Image /page/8/Picture/4 description: The image contains the logo for Kettenbach Dental. The logo consists of a blue triangle made of circles, with the text "KETTENBACH DENTAL" written vertically next to it. Below the company name, the words "Simply intelligent" are written in a smaller font. The image also contains the words "STEPH Production Station of Controller Station of Controller Station of Controllers of Controllers of Controllers of Controlle".

Manufacturer	Predicate DevicesVenus Bulk Flow ONEKulzer, LLC- Extended fissure sealing	Substantial Equivalent DeviceVisalys® Bulk FillKettenbach GmbH & Co. KG- Splinting / locking of teeth	Visalys® Bulk Flow	Conclusion
Basic formulation	Venus Bulk Flow ONE is alight-curing methacrylate-based formulation with thefollowing ingredients:Barium aluminium boro-fluoro-silicate glass,E4BADMA, UDMA,ytterbium fluoride, siliciumdioxide, titanium dioxide,BHT, aminobenzoic acidester, camphorquinone,fluorescent pigments, metaloxide pigments, organicpigments. Venus Bulk FlowONE contains approx. 41 %filler by vol., the particle sizeof which is 20 nm – 5 µm.	Main components ofVisalys® Bulk Fill areapprox. 61 vol. %inorganic fillers in the sizerange 0.01 – 5 μmincluding ytterbiumfluoride. The polymerbase consists of aliphaticdimethacrylates.	- Repair of direct andindirect restorations afterappropriate pretreatment- Extended fissure sealing- Splinting / locking ofteethMain components ofVisalys® Bulk Flow areapprox. 47 vol. %inorganic fillers in the sizerange 0.01 – 5 μmincluding ytterbiumfluoride. The polymerbase consists of aliphaticdimethacrylates.	The basic formulation issimilar. The products aremethacrylate based andcontain inorganic fillersincluding ytterbiumfluoride. The particle sizes are thesame.
Available shades	Universal shade	Universal shade	Universal shade	The products are availablein a one-shade system forall tooth shades.
Single use	Single use only	Single use only	Single use only	The products are singleuse devices.
Application system	Syringe (2 g)	Syringe (4 g)Cap (0.25 g)	Syringe (2 g)Cap (0.25 g)	All products are available ina syringe. Visalys® Bulk Filland Visalys® Bulk Flow arealso offered in a cap.
Performancetesting	A comparison of the parameters in respect to mechanical properties was performed. The results demonstrate thesubstantial equivalence to the predicate device.
Summary ofProduct	The indication of the subject devices is the same for the predicate device. Contraindications, application, and sideeffects for both products are basically the same – there is a slight difference in the wording.

510k Summary Issued: 2025-03-14

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Image /page/9/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of a blue triangle made up of six circles on the left, with the text "KETTENBACH DENTAL" to the right of the triangle. Below the company name is the slogan "Simply intelligent".

	Predicate Devices	Substantial Equivalent Device	Conclusion
Product	Venus Bulk Flow ONE	Visalys® Bulk Fill	Visalys® Bulk Flow
Manufacturer	Kulzer, LLC	Kettenbach GmbH & Co. KG
Description,Intended purposeIndications,Contraindications /Precautions
SummaryChemicalComposition		The Visalys® Bulk Flow formulation has been thoroughly assessed for biocompatibility. The results for Visalys® BulkFlow covers Visalys® Bulk Fill since the most relevant ingredients from a toxicological standpoint are present in ahigher concentration in Visalys® Bulk Flow.
Summary ofFinishedDeviceSpecification		The results demonstrate the substantial equivalence to the predicate device.

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●
Toxicological risk assessment
Chemical characterization ●
- Evaluation of biocompatibility

The tests showed that the biocompatibility data of Visalys® Bulk Flow (and therefore Visalys® Bulk Fill) is comparable to other materials on the market. Hence, no toxicological risks and resulting hazards for patients, users and third parties can be concluded.

Non-clinical performance:

According to ISO 4049 "Polymer-based restorative materials" bench testing was performed to allow an evaluation of the mechanical properties of Visalvs® Bulk Fill and Visalys® Bulk Flow in comparison to Venus Bulk Flow ONE (K220605).

Sensitivity to light	Acc. to ISO 4049 / 7.9
Depth of cure	Acc. to ISO 4049 / 7.10
Flexural strength	Acc. to ISO 4049 / 7.11
Elastic modulus	Acc. to ISO 4049 / 7.11
Water sorption	Acc. to ISO 4049 / 7.12
Solubility	Acc. to ISO 4049 / 7.12
Shade of restorativematerials	Acc. to ISO 4049 / 7.13and ISO 7491 / ANSI ADA Spec. 80
Color stability after irradiationand water sorption	Acc. to ISO 4049 / 7.13and ISO 7491 / ANSI ADA Spec. 80
Radio-opacity	Acc. to ISO 4049 / 7.14and ISO 13116
Volume shrinkage	Acc. to ISO 17304
Shear bond strength to dentin	Acc. to ISO 29022
Shear bond strength torestorative materials	Acc. to ISO 29022
Duration of light curing	Internal test method
Extrusion force1)	Internal test method
Consistency2)	Internal test method
High shear viscosity1)	Internal test method
Low shear viscosity1)	Internal test methods
Universal color	In-vitro test

VII. Performance Data:

Biocompatibility:

The following performance data were provided in substantial equivalence determination. The biocompatibility evaluation was conducted in accordance with ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.:

. Cytotoxicity
Sensitization
Genotoxicity
ISO 10993-10 ISO 10993-3

ISO 10993-5

ISO 10993-17
ISO 10993-18
ISO 7405

Image /page/10/Picture/23 description: The image contains the text "Rev.2". The text is written in a simple, sans-serif font. The letters are black against a white background.

Image /page/10/Picture/24 description: The image shows the logo for Kettenbach Dental. The logo consists of six blue circles arranged in a triangular pattern above the text "KETTENBACH DENTAL" in blue. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.

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Image /page/11/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo features a graphic of six blue circles arranged in a triangular shape above the company name. The text "KETTENBACH" is in a bold, sans-serif font, and the word "DENTAL" is in a lighter, slightly smaller font. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.

Test just for Visalys® Bulk Flow; 2) Test just for Visalys® Bulk Fill Summary:

Based on the performance data, Visalys® Bulk Fill and Visalys® Bulk Flow were found to have a safety and effectiveness profile that is similar to the predicate device.

Clinical Performance Data:

Data from clinical studies was not provided.

VIII. Conclusion:

Based on similarities in technology and indications for use, together with results on nonclinical performance testing, Visalys® Bulk Fill and Visalys® Bulk Flow are substantially equivalent to the predicate device Venus Bulk Flow ONE (K220605).

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.